Posts Tagged ‘requirements’
ISO 9001 Is It Just Another Expense?
When I hear a manager say ISO 9001 is just another expense, I immediately know that this organization doesn’t have a clue what ISO 9001 is. Lip service is just that, if you put nothing into your quality management system, you will get exactly nothing in return. ISO 9001 is a quality standard which aims to guide an organization to understand its own business better so that it can meet or exceed its customer needs. By implementing a “successful” quality system the organization will see tangible improvements that lead to reduced costs and increases in market share.
How does this happen, the reduced costs and increased market share? Well if you think just because you plop a system in, you will instantly see the money, think again. This is a process, a process that develops and matures over time which is spurred on by increased awareness and understanding throughout the organization. As you learn more about your internal processes and link them to your customer needs, you will begin to reap the rewords of your efforts.
So get serious about your companies goals and how you will achieve them, (plan) your processes, work your system (Do), (Check) your progress toward achieving your objectives, and make the necessary changes along the way to keep on track (Act). If you are like so many other companies out there, you could use a little help getting started. There are plenty of quality consultants and classes that can do just that. But once you finally “GET IT; your system should become an effortless process that runs like a Swiss watch. This process should not add work or drain resources; rather it should run itself because it is how you do business every day.
Don’t get involved in ISO 9001 with the belief that it is just another expense. Make the process pay for itself by understanding, believing and promoting, and driving your goals and expectations to completion. Lead and you will succeed, or don’t and throw your money and future expectations away. One thing is for sure at the end of the day, if you don’t put your best foot forward, somebody else will.
ISO 9001: Management Review What’s It All About?
Section 5.6 if the ISO 9001:2008 standard requires that top management reviews the organizations quality management system in order to determine its continued suitability, adequacy and effectiveness. There are many ways to satisfy this requirement. Many companies miss interpret this passage to mean they must have a meeting specifically to satisfy this section of the standard. Some companies even go so far as to impose mandatory monthly meeting for this purpose. The standard does not say anything about a meeting, it says you must review the inputs and out puts of your processes at planned intervals.
You must decide how often it is necessary to carry out the review of the required inputs and outputs and how you will review them. You can have several meeting during a given time period during which you address one or more of the requirement at each meeting, (production meetings, customer service sales meetings, quality MRB meetings, annual state of the business meetings, safety meetings, etc). You may decide that top management can satisfy this requirement by individually reviewing the inputs and outputs of the QMS electronically and communicating the results to the organization through action plans to individual departments, group meetings, or supervisor dissemination to the work force. You may decide to go the traditional route and have scheduled management review meetings quarterly or yearly.
The key here is you must decide how and when, and then you must make sure this plan is carried out. When deciding, keep in mind the purpose of this exercise is continual improvement. Don’t invent an elaborate review process that does not add value, make it work for you.
What Is The Objective Of the AS9100 Rewrite?
The objectives of AS9100:2009 are to:
- Incorporate ISO 9001:2008 changes
- Expand the scope to include aviation, space, and defense as well as land and sea based systems for defense applications
- Ensure alignment with IAQG strategy (On-Time and On-Quality Delivery performance)
- Adopt new requirements based on stakeholder needs
- Improve existing requirements where stakeholders identified a need for clarification, including when a documented quality management procedure is required
There are major changes to the AS9100:2009 release that affect how companies implement AS9100 for the first time or upgrade from a previous version of the standard:
- A customer focus on On-Time and On-Quality Delivery performance in the Aerospace, Defense, and Space Industries, which will directly impact the implementation as a whole.
- A significant focus on Planning and Project Management including characteristics flow down
- A significant increased role for risk management and mitigation
- Changes companies need to focus on from ISO 9001:2008
- A major change in the auditing from a “checklist focus” to Performance Auditing from AS9101
What Is The QMS Scope For ISO 9001?
The scope of the QMS should be based on the nature of the organization’s products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.
While ISO 9001 is generic and is applicable to all organizations (regardless of their type, size or product category), under certain circumstances, an organization may exclude complying with some specific ISO 9001 requirements (from clause 7), while being permitted to claim conformity to the standard. This is because it has been recognized that not all the requirements in this clause of the standard are relevant to all organizations.
To enable identification of what has been registered/certified, the scope of registration/certification should clearly define:
*the scope of the quality management system (including details of the product lines and related sites, departments, divisions etc. that are covered by it)
*the organization’s main processes for its product realisation or service delivery activities (such as design, manufacture and delivery), for the product lines that are covered
*any ISO 9001 requirement that has been excluded
AS 9100: How Often Will We Be Audited?
Each type of audit will have its own schedule. Often companies will have more frequent internal audits than third-party audits, especially during the early stages of your as9100 certification and implementation. These early audits help employees become more comfortable with the audit process, eliminate any problems in the quality management system, and thus help ensure the company will “pass” the registration audit.
ISO 9001 Return On Investment
The ISO 9001standard is not designed to tell you how to run your business, but instead give you a basis to comply with the requirements in a way that best meets your specific business goals, requirements, needs, and environment, etc. On the range from “no quality system” to “world-class quality system,” an ISO 9001 quality management system is a starting point roughly in the middle. It is not in itself going to radically change someone’s business. It is however a place to begin and many industries have used it as such. Aerospace, automotive, and chemicals are a few examples of industries that began with ISO 9001 and added additional requirements for their suppliers and partners. Many companies do the same. They begin with ISO 9001, learn, improve, and continually build on their management system.
Should you implement an ISO 9001 quality management system? And, should you certify your ISO 9001 system? As companies undertake the initiative, they look for the benefit and return on investment. A quality management system that is ISO 9001 certified provides discipline, improves processes and increases the productivity and effectiveness of the companies’ operations. Consistent, reliable, well documented quality management systems result in reduced scrap and waste, less human errors, and therefore increased profitability and customer satisfaction.
Essential Changes To The Continual Improvement Of AS9100
The scope was changed from aerospace to aviation, space and defense to recognize that complex systems can include multiple sectors.
The requirement to include quality system requirements imposed by regulatory authorities when developing QMS documentation
Special requirements are those identified by the customer or determined by the organization that has high risks to being achieved
Critical items (for example, functions, parts, software, characteristics and processes) are those having significant effect on product realization and use of the product.
This new requirement requires product conformity and on-time delivery be measured and appropriate actions be taken if planned results are not achieved.
This revision has added a requirement to monitor customer satisfaction data and develop improvement plans that address deficiencies.
Using various business management systems tools can help an organization achieve organizational excellence and satisfy necessary requirements set forth in this new revision of AS9100. AS9100 software as well as AS9100 templates have been developed, that can guide an organization to succeed with meeting this new challenge. Let’s face it, most small business today do not have the resources and cash that the big guy do. These tools are being used as an alternative to high cost consulting services.
AS9100 Fast Becoming A Supplier Requirement
The aerospace industry has recognized AS9100 as a means for continually improving quality and on-time delivery within their supply chain. Most of the major aircraft engine manufacturers, such as General Electric’s Aircraft Engine division (GEAE), Boeing, Rolls-Royce Allison and Pratt & Whitney, are requiring their suppliers to be certified to AS9100.
AS9100 certification can be used throughout the entire aerospace supply chain including the design and manufacture of airport and airline operations, replacement parts, supply and maintenance, cargo handling, overhaul and repair depots and flight operations.
The industry is moving towards requiring their suppliers to be AS9100 compliant / certified. By becoming AS9100 compliant / certified, suppliers can gain a competitive advantage and benefit from the process approach and continual improvement that are the foundation of ISO 9001:200* certified QMS.
Currently, the Boeing Company requires all Boeing suppliers to be BQMS (Boeing’s Quality Management System) approved or have a waiver. AS9100 Rev B is a significant part of Boeing’s BQMS requirements.
General Electric Aircraft Engines (GEAE) was one of the first manufacturers to require AS9000 compliance by all of their direct material suppliers. Currently, GEAE is requiring AS9100 certification for all new suppliers, and existing suppliers have a gap audit and a certification audit performed to coincide with their existing surveillance audit schedule.
The benefits of ISO 9001 when implemented correctly
The main purpose of implementing an ISO 9001 system is to improve a process, eliminate waste, save money and ensure that the company will be a contender in future markets. Every process in a company should have a measurement that shows if it is effective and/or met the desired result (the plan). The best platform to improve a process is when the quality policy and measurable objectives are defined clearly, and communicated clearly throughout an organization.
In many instances, a company will not be able to find a way to measure the effectiveness of a certain process or understand how it feeds into overall goals and objectives. In these instances one must further investigate what is the purpose of this process and if it should be eliminated or modified to satisfy the company’s objectives—the why and what if questions.
Some business process reengineering steps are extremely difficult to measure and define, such as a process required to meet a safety requirement, regulatory requirement or customer requirement. It also is important to include the performance indicators of processes so that when an action is taken (corrective or preventive) the effectiveness of those actions can be measured. The most effective method to measure effectiveness is to measure and track costs. This includes cost of nonconformity so when problems are corrected and processes improved, cost savings can be measured.
Business Process Improvement a Survival Tactic
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For most manufacturers, the need to maintain or improve financial performance is urgent. This is leading many companies to close manufacturing facilities and either move production operations offshore to low-cost countries or to outsource manufacturing to other companies. However, many other manufacturers are surviving and thriving in North America, Europe, Japan, and other high-cost countries.
Effective manufacturing improvement projects – focused on areas of urgent business need – are a critical component to these manufacturers’ success. Leading manufacturers are meeting requirements at every step that make their plant projects successful, starting at conception and following through its entire lifecycle. Successful manufacturing improvement projects can spell the difference between a profitable plant and one that’s history.
The benefits to having your company go through the registration process for ISO 9001 or AS 9100 are ten fold:
1. Increased Efficiency
2. Increased Revenue
3. Improved Employee Morale
4. International Recognition
5. Factual Approach to Decision Making
6. Improved Supplier Relationships
7. Documentation that ensures consistency of process
8. Consistency of product or service
9. Improved Customer Satifaction
10. Improvement Processes that lower costs and ensure continued success
